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  • Study shows reduced bleeding risk with ticagrelor monotherapy after percutaneous coronary intervention

    Study shows reduced bleeding risk with ticagrelor monotherapy after percutaneous coronary intervention

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    People who have had a heart attack or who are at risk for a heart attack and who stopped taking aspirin alongside the P2Y12 inhibitor ticagrelor one month after undergoing percutaneous coronary intervention (PCI) saw a significantly reduced risk of clinically meaningful bleeding with no increased risk of clotting-related adverse events at 12 months compared with patients who continued taking aspirin and ticagrelor for a full year, in a study presented at the American College of Cardiology’s Annual Scientific Session.

    The ULTIMATE-DAPT study is the first placebo-controlled trial designed to examine ticagrelor monotherapy following one month of dual antiplatelet therapy (DAPT) after PCI, a procedure to open blocked arteries. The study focused on patients who underwent PCI for acute coronary syndromes (ACS)—life-threatening conditions which include heart attacks and chest pain caused by decreased blood flow to the heart—with stents containing drugs to prevent further plaque buildup.

    In treating a broad range of patients with acute coronary syndromes in the era of contemporary drug-eluting stents, among those who were stable after one month of DAPT, continuing treatment with ticagrelor alone reduced bleeding with no increase in adverse ischemic thrombotic events. These data suggest that a 12-month duration of DAPT is not only not necessary in most patients with ACS but is harmful.”


    Gregg Stone, MD, professor of cardiology and population health sciences at Icahn School of Medicine at Mount Sinai, New York and co-chair of the trial

    Antiplatelet medications reduce clotting-related cardiovascular problems such as heart attacks and strokes by preventing platelets from sticking together. To reduce the risk of such events after PCI, current guidelines recommend that most patients should take two antiplatelet medications—aspirin and a P2Y12 inhibitor—for a full year. However, the bleeding risk associated with antiplatelet medications has fueled efforts to further optimize the duration of post-PCI antiplatelet therapy and the medications used to balance the benefits and risks.

    For ULTIMATE-DAPT, researchers enrolled 3,400 patients who experienced no adverse cardiovascular or bleeding events in the first month following PCI for ACS at 58 medical centers in four countries in Asia and Europe. During the first 30 days after PCI, all patients took aspirin and ticagrelor, a potent P2Y12 inhibitor. Participants were then randomly assigned to continue with this same regimen for 11 more months or to switch to ticagrelor and a placebo.

    The trial met its two primary endpoints, one assessing efficacy in terms of bleeding risk and the other assessing safety in terms of clotting-related events. The first endpoint, clinically relevant bleeding, occurred in 4.6% of patients assigned to continuing DAPT and 2.1% of patients assigned to take ticagrelor and a placebo, a significant reduction in favor of ticagrelor alone. The second endpoint, a composite of major adverse cardiovascular events and cerebrovascular events, showed no significant difference between groups, with 3.7% of patients who continued DAPT and 3.6% of those taking ticagrelor and a placebo experiencing such events.

    The streamlined therapy of treating patients with ACS with ticagrelor alone one month after PCI was equally safe and effective in patients who presented with a heart attack (the highest risk group) or were at risk of a heart attack. Together, these findings suggest that patients who stopped taking aspirin after the first month had a substantially reduced risk of bleeding without any increased risk of thrombotic events, researchers said.

    “The next question is how will physicians incorporate these results into their daily practice, and what will guideline committees ultimately do with these data,” Stone said. “I believe these results are very convincing and align with prior studies done without a placebo; hopefully they will impact guidelines and lead to the routine use of only one month of DAPT followed by a potent P2Y12 inhibitor such as ticagrelor in most patients with ACS after successful PCI.”

    Since the trial only involved ticagrelor, researchers said that separate studies would be necessary to investigate the safety and efficacy of a similar approach using other P2Y12 inhibitors, such as prasugrel and clopidogrel.

    The study was funded by the Chinese Society of Cardiology, the National Natural Scientific Foundation of China and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. Stents were supplied by Medtronic Corp. (Minnesota, U.S.) and Microport Medical (Shanghai, China). Study medications were supplied by Yung Shin Pharmaceutical Industrial Co. (Kunshan, China) and Shenzhen Salubris Pharmaceuticals Co., Ltd (Shenzhen, China).

    This study was simultaneously published online in The Lancet at the time of presentation.

    Stone will be available to the media in a press conference on Sunday, April 7, 2024, at 11:15 a.m. ET / 15:15 UTC in Room B203.

    Stone will present the study, “One-month Ticagrelor Monotherapy After PCI in Acute Coronary Syndromes: Principal Results from the Double-blind, Placebo-controlled Ultimate DAPT Trial,” on Sunday, April 7, 2024, at 9:45 a.m. ET / 13:45 UTC in the Hall B-1 Main Tent.

    Source:

    American College of Cardiology

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  • Novel cholesterol removal strategy shows potential benefits post-heart attack

    Novel cholesterol removal strategy shows potential benefits post-heart attack

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    The first trial of a novel strategy for removing cholesterol from patients’ arteries did not reduce the risk of death, heart attack or stroke within three months of a prior heart attack, according to research presented at the American College of Cardiology’s Annual Scientific Session. However, the findings suggest that the strategy may be beneficial with longer follow-up.

    We did not see a statistically significant reduction in the primary endpoint of risk for death, a heart attack or a stroke at 90 days, or a reduction in risk for stroke at any time.”


    C. Michael Gibson, MD, professor of medicine at Harvard Medical School and study’s lead author

    However, in an exploratory analysis of outcomes, treated patients had fewer heart attacks and heart-attack deaths than patients in the control group at six months, he said.

    “Although we missed our primary endpoint, our data support the hypothesis that HDL cholesterol plays a role in reducing subsequent coronary plaque disruption events like heart attack via enhanced cholesterol efflux attacks,” Gibson said.

    People who have had a heart attack are at high risk for another one, especially during the next 90 days, Gibson said. This study was the first in which patients received an infusion of ApoA-I, a component of HDL (“good”) cholesterol, shortly after a heart attack, with the aim of stabilizing coronary plaque and reducing adverse cardiovascular events. The investigational drug CSL112 used in the study is a form of ApoA-I that’s extracted from human plasma, the liquid component of blood.

    High levels of LDL cholesterol create a build-up of plaque in the arteries that carry blood to the heart, increasing risk for an arterial blockage that causes a heart attack. HDL cholesterol removes cholesterol from the arteries and carries it to the liver, which then excretes it. ApoA-I, the main component of HDL cholesterol, helps initiate the process of removing cholesterol from the body. A previous study showed that a single infusion of CSL112 reduced the amount of LDL cholesterol in arterial plaque by as much as 50%.

    Other studies have shown that high levels of HDL cholesterol are associated with reduced heart attack risk. Recent research, however, suggests that the level of HDL cholesterol number may be less important for reducing heart attack risk than how well it performs at removing cholesterol, Gibson said.

    “We know that in the setting of a heart attack, when the HDL cholesterol is good at getting a lot of cholesterol out of the arteries, that results in better outcomes for patients,” he said.

    Gibson and his colleagues hypothesized that infusions of CSL112 given shortly after a heart attack might—by boosting the body’s ability to dispose of cholesterol—reduce patients’ risk for a repeat heart attack during the next crucial 90 days. The international AEGIS-II trial, conducted in 49 countries, was designed to test this hypothesis.

    The study enrolled 18,219 patients (median age 65.5 years, 74% men and 84.5% White) who had been hospitalized for a heart attack and had multiple blockages in arteries carrying blood to the heart that elevated their risk for another heart attack. They also had other risk factors, including having had a previous heart attack, receiving drug treatment for diabetes or being 65 or older. Patients were randomly assigned to receive infusions of either CSL112 or a placebo for four weeks, with the first infusion given within five days of hospitalization.

    The study’s primary endpoint was the time to the first occurrence of a major adverse cardiovascular event (MACE; i.e., heart attack, stroke or death due to heart disease or a stroke) at 90 days. Secondary endpoints included the time to the first occurrence of a MACE within six months and one year and of each specific event within 90 days, six months and one year.

    At 90 days, patients treated with CSL112 had a 4.8% reduction in risk for death, heart attack or stroke compared with 5.2% for those treated with a placebo, a difference that was not statistically significant. In an exploratory analysis, however, patients treated with CSL112 were 14% less likely to have or die from a heart attack at 180 days. In addition, patients treated with CSL112 were 32% less likely to have a heart attack caused by a blood clot in a stent (a tiny mesh tube inserted into an artery to prevent it from becoming blocked) at 90 days and 29% less likely at 180 days.

    Another potentially important finding, Gibson said, is that patients whose LDL cholesterol level was 100 mg/dL or higher at study entry experienced a 30% decrease in the primary endpoint, a statistically significant finding, whereas patients whose LDL cholesterol at study entry was less than 100 mg/dL saw no decrease in the primary endpoint.

    “Baseline LDL modulated the treatment effect,” Gibson said.

    “Overall, our findings are consistent with ApoA-I having a role in stabilizing heart blockages and reducing the risk of a blockage that ruptures and causing a heart attack further out than 90 days,” Gibson said. “It’s plausible that by giving ApoA-1 to clear the cholesterol out of the body and then treating the patient with cholesterol-lowering medications to keep LDL cholesterol levels low, we could see reductions in deaths and heart attacks that continue over time.”

    Future research will focus on identifying high-risk patients who might benefit from this approach, he said.

    An antiplatelet effect of CSL112 or a reduction of cholesterol in the arteries resulting from treatment with CSL112 could also explain the significant reduction in the number of heart attacks caused by a blood clot in a stent, he said. The reason strokes were not reduced may be that strokes can be caused by mechanisms other than the rupture of arterial blockages, he said.

    A limitation of the study is that women, Black people and people of Asian heritage were underrepresented, which could reduce the findings’ generalizability, Gibson said.

    The study was funded by CSL Behring, the manufacturer of CSL112.

    This study was simultaneously published online in the New England Journal of Medicine at the time of presentation. The findings of the exploratory analysis were/will be published in the Journal of the American College of Cardiology.

    Gibson will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

    Gibson will present the study, “Patients With Acute Myocardial Infarction (ApoA-I Event Reducing In Ischemic Syndromes II (AEGIS-II) Trial): Primary Trial Results,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

    Source:

    American College of Cardiology

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  • Empagliflozin shows mixed results in heart attack patients

    Empagliflozin shows mixed results in heart attack patients

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    Use of the sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin following a heart attack did not show a significant benefit in reducing overall heart failure hospitalizations or death from any cause, according to a study presented at the American College of Cardiology’s Annual Scientific Session. However, researchers said the drug may be helpful in reducing heart failure risks, including hospitalization, following a heart attack.

    Despite falling short of its primary endpoint, results from the EMPACT-MI trial found that people who took empagliflozin had a significantly lower risk of certain outcomes directly related to heart failure, including first hospitalization for heart failure, total hospitalization for heart failure and a composite of heart failure hospitalization and death from heart failure, without any increased risk of adverse events.

    We found that empagliflozin did not reduce mortality after a heart attack but did reduce the risk of heart failure after heart attack. To have a 25% to 30% reduction in heart failure hospitalizations is pretty clinically meaningful, but if you put it together with all-cause mortality, it was not a positive study for our primary endpoint.”


    Javed Butler, MD, president of the Baylor Scott and White Research Institute in Dallas, distinguished professor of medicine at the University of Mississippi in Jackson, Mississippi, and study’s lead author

    SGLT-2 inhibitors were initially approved to treat Type 2 diabetes by lowering blood sugar. As evidence has mounted pointing to their benefits in reducing heart failure and other forms of heart disease, researchers have sought to determine whether these drugs could help to prevent heart failure even in people without diabetes or chronic kidney disease.

    A heart attack can damage the heart muscle in ways that sometimes lead to heart failure, a condition in which the heart becomes too weak or too stiff to effectively pump blood throughout the body. The EMPACT-MI trial was designed to determine whether SGLT-2 inhibitors could safely help to prevent heart failure and reduce mortality in people with a high risk of heart failure following a heart attack.

    The study enrolled 6,522 people treated for acute myocardial infarction at 451 centers in 22 countries. Participants had no history of heart failure but had at least one heart failure risk factor in addition to signs of potential heart dysfunction as indicated by a newly lowered left ventricle ejection fraction to below 45% and/or signs or symptoms of congestion requiring treatment. About 32% had Type 2 diabetes. On average, participants were 64 years old and approximately 25% were women and 84% were White.

    Within 14 days of being admitted to the hospital for a heart attack, half of the participants were randomly assigned to receive empagliflozin at a dose of 10 mg daily, while the other half received a placebo. Researchers tracked outcomes for a median of just under 18 months.

    The study’s primary composite endpoint occurred in 8.2% of those who received empagliflozin and 9.1% of those receiving a placebo, a difference that was not statistically significant. There was also no difference in the rate of death from any cause, which occurred in 5.2% of those receiving empagliflozin and 5.5% of the control group.

    All secondary endpoints related specifically to heart failure outcomes were significantly reduced among patients who received empagliflozin. For example, those receiving empagliflozin were 23% less likely to experience a first heart failure hospitalization and 33% less likely to experience any heart failure hospitalization—including recurrent hospitalizations—compared with those taking a placebo. The composite rate of total heart failure hospitalizations and death from heart failure was also 31% lower among those receiving empagliflozin.

    Among patients who were not taking common heart failure therapies such as diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor/neprilysin inhibitor (ARNI) at the time of their initial hospital discharge, those taking empagliflozin were significantly less likely to start such therapies within six months compared with those taking a placebo.

    “In terms of heart failure outcomes, the data is not only strong, but it’s consistent with what we’ve found over the past 10 years in yet another population,” Butler said. “This finding is completely consistent in both direction and magnitude with other studies of SGLT-2 inhibitors in populations with diabetes and chronic kidney disease.”

    While as a pragmatic trial design to simplify trial procedures and make it easier on both the participants and the sites, the study had limitations that may have influenced the findings, researchers said. For example, because outcomes were not adjudicated by independent reviewers, outpatient heart failure events were not formally captured as part of the primary endpoint. However, researchers said data on outpatient heart failure visits were collected as part of the study protocols for assessing adverse events. An analysis of these events showed outpatient visits for heart failure were substantially lower in participants who received empagliflozin compared with placebo.

    Another limitation was the use of all-cause mortality as part of the primary endpoint, which meant that deaths unrelated to heart failure were included in the endpoint even though the study drug was unlikely to influence them. There were also some unusual circumstances that may have influenced rates of both hospitalization and death, including the COVID-19 pandemic and conflicts involving Russia, Ukraine and Israel, all countries that participated in the trial.

    Finally, researchers said that the follow-up period may have been too short to fully capture any difference in mortality related to heart failure. Since people who developed heart failure following their heart attack typically did not begin to show heart failure symptoms until a few months later, any reductions in mortality would not be expected to emerge until after that.

    “We just did not have long enough follow-up to see whether that heart failure prevention would lead to a benefit in mortality, but it’s a reasonable clinical thing to say that if you’re preventing heart failure, it’s a good thing,” Butler said.

    The study was funded by Boehringer Ingelheim and Eli Lilly.

    This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

    Butler will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

    Butler will present the study, “Empagliflozin After Acute Myocardial Infarction: Results of the EMPACT-MI Trial,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

    Source:

    American College of Cardiology

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  • Interatrial shunt may offer differential benefits based on heart failure type

    Interatrial shunt may offer differential benefits based on heart failure type

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    Patients with heart failure who had a small shunt inserted between the heart’s left and right atria did not see any significant benefits overall compared with those who received a placebo procedure after a median of 22 months follow-up, in a study presented at the American College of Cardiology’s Annual Scientific Session.

    The trial, called RELIEVE-HF, is the first randomized placebo-procedure controlled trial of interatrial shunting that included patients with both major types of heart failure: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). While the trial did not meet its primary endpoint, it moves the field forward by offering signals that the benefits and risks of interatrial shunts may vary by heart failure type, according to researchers.

    When you examine the outcomes in patients with heart failure across a broad range of left ventricular ejection fraction, the Ventura interatrial shunt was extremely safe but did not improve outcomes compared with no treatment. However, in a prespecified analysis, data suggest that the shunt may be beneficial in patients with HFrEF and worsen outcomes in patients with HFpEF. We believe further studies are warranted to confirm the benefits we observed in patients with reduced ejection fraction.”


    Gregg Stone, MD, professor of cardiology and population health sciences at Icahn School of Medicine at Mount Sinai in New York and study’s first author

    Heart failure is a condition in which the heart becomes too weak or stiff to effectively pump blood, leading to fatigue, organ damage, shortness of breath and an increased risk of life-threatening cardiovascular events. In HFrEF, the heart muscle becomes weak and does not squeeze as hard as it should. In HFpEF, the left ventricle becomes stiff and does not properly fill with blood.

    The Ventura shunt is one of several interatrial devices being tested to aid in the treatment of heart failure. It is designed to form a small connection or passage between the left and right atria to allow blood to leave the left atrium—especially as left atrial pressure rises—thus reducing the pressure in the left atrium and the lungs. High left atrial pressure is a primary cause of shortness of breath and hospitalizations related to heart failure.

    The trial randomized 508 patients at 94 sites in North America, Europe, Israel, Australia and New Zealand. All participants had symptomatic heart failure despite taking medications at maximally tolerated doses. About 40% of participants had HFrEF and 60% had HFpEF.

    Participants were randomly assigned to undergo a procedure to insert the Ventura shunt or a placebo procedure in which a script was followed with all the same protocols to mask patients as to whether the shunt was inserted. Operators were aware of which procedure each patient received but patients, their families and the rest of the medical teams taking care of the patient after the procedure were not. Researchers tracked outcomes in each participant for at least one year and up to two years.

    The results showed no significant difference between groups in terms of the trial’s primary endpoint, a hierarchical composite ranking of death from any cause; heart transplant or left ventricular assist device; heart failure hospitalizations; worsening of outpatient heart failure events; and change in quality of life, as measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). This hierarchical composite approach for assessing efficacy allows diverse types of outcomes to be incorporated in ranked fashion into an overall “win ratio” reflecting the overall outcome of a drug or device.

    In a pre-planned analysis focused on heart failure type, patients with HFrEF who received the shunt were found to have improvements across all outcomes assessed (especially fewer hospitalizations for heart failure), while those with HFpEF who received the shunt were found to have increased rates of death and heart failure hospitalizations. This difference could be attributed to the greater compliance or flexibility of the heart muscle with HFrEF, potentially allowing it to more easily accommodate the extra blood flowing into the right atrium, Stone said.

    There were no device-related or procedure-related major adverse cardiovascular or neurologic events in either group during the duration of the trial.

    Surprisingly, a marked improvement in quality of life as measured with KCCQ was observed across all groups—including those who received a placebo procedure, both with HFrEF and HFpEF—suggesting that the metric may not be a reliable indicator for quality-of-life outcomes in this context, Stone said.

    “There was a tremendous placebo effect,” he said. “These observations, especially the fact that quality of life improved in HFpEF patients who were more likely to be hospitalized for heart failure and had reduced survival after shunt treatment, raise questions about the interpretation of this quality-of-life measure in these kinds of trials.”

    Although the observed differences in outcomes among people with different types of heart failure may inform future research and development for interatrial devices, the researchers said that the trial was not powered to show differences in the two types of heart failure. As such, these results should be considered exploratory. They also said that the results may not be applicable to other interatrial shunts beyond the Ventura shunt.

    The study was funded by V-Wave Medical.

    Stone will be available to the media in a press conference on Saturday, April 6, 2024, at 10:45 a.m. ET / 14:45 UTC in Room B203.

    Stone will present the study, “A Double-blind, Randomized Placebo Procedure-controlled Trial of an Interatrial Shunt in Patients with HfrEF and HfpEF: Principal Results from the RELIEVE-HF Trial,” on Saturday, April 6, 2024, at 9:30 a.m. ET / 13:30 UTC in the Hall B-1 Main Tent.

     

    Source:

    American College of Cardiology

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  • Investigational drug plozasiran shows promise in reducing severe hypertriglyceridemia

    Investigational drug plozasiran shows promise in reducing severe hypertriglyceridemia

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    In patients with severely elevated triglyceride levels at risk for developing acute pancreatitis, the investigational drug plozasiran reduced triglyceride levels by an average of 74% after 24 weeks of use without causing any significant safety concerns, according to research presented at the American College of Cardiology’s Annual Scientific Session.

    Plozasiran produced significant reductions in triglyceride levels below the threshold associated with elevated risk for pancreatitis, with a favorable safety profile. These data support the initiation of pivotal studies of plozasiran for the treatment of severe hypertriglyceridemia.”

    Daniel Gaudet, MD, PhD, professor of medicine at the University of Montreal and the study’s lead author

    Triglycerides are blood lipids (fats) that store unused calories and provide energy to the body. An estimated 1 in 5 U.S. adults—and more than 2 in 5 of adults aged 60 years and older—have elevated triglycerides, defined as over 150 mg/dL. High levels of triglycerides and the lipid particles on which they are carried in the blood can contribute to the formation of “plaques” in the arteries that impede blood flow and can lead to heart attacks and strokes. Severe hypertriglyceridemia—defined as triglyceride levels over 500 mg/dL—can also cause pancreatitis, an inflammatory process in the pancreas that can be life threatening.

    ApoC3 is a protein produced in liver cells that inhibits the liver’s ability to clear fats such as triglycerides out of the body. Plozasiran works by reducing the production of ApoC3, thereby enabling the liver to increase its clearance of triglycerides and other fats. The SHASTA-2 trial tested the effectiveness and safety of plozasiran as an add-on to existing lipid-lowering treatment in patients with severe hypertriglyceridemia.

    A total of 229 patients (average age 55 years, 78% men and 90% White) were enrolled in the trial in eight countries. Patients’ average triglyceride level at baseline was about 900 mg/dL. Most also had at least three of the following risk factors: elevated risk for or history of cardiovascular disease, diabetes, low HDL (“good”) cholesterol and high body mass index.

    Patients were randomly assigned to one of four groups. Three groups received two injections of plozasiran at one of three doses (10 mg, 25 mg or 50 mg); the fourth group received two injections of a placebo. The first injection was given on day one and the second at week 12. The study was double-blinded, meaning that neither the patients nor their clinicians knew who was receiving the drug and who was receiving the placebo until the study was over.

    The study’s primary endpoint was the percentage change in fasting triglyceride levels from study entry to 24 weeks. Secondary endpoints included the percentage change in ApoC3 at 24 weeks and every four weeks from baseline through 48 weeks and in fasting triglyceride levels every four weeks through 48 weeks. All patients were followed for 36 weeks after the second dose (for a total of 48 weeks).

    At 24 weeks, the average reduction in triglyceride levels in plozasiran-treated patients was 74%, compared with 17% in patients who received the placebo. At 48 weeks the average reduction was 58% in patients who received the highest doses of plozasiran compared with 7% for those in the placebo group. The average reduction in ApoC3 was 78% for plozasiran-treated patients versus 1% for the placebo group at 24 weeks. At 48 weeks, ApoC3 levels were reduced by 48% on average among patients receiving the highest doses of plozasiran, whereas ApoC3 levels increased 4% in the placebo group.

    At 24 weeks, over 90% of patients who received the higher doses (25 mg or 50 mg) of plozasiran saw their triglyceride levels fall to below 500 mg/dL, the commonly accepted threshold for an increase in risk for pancreatitis. At 48 weeks, 77% of these patients still had triglyceride levels of less than 500 mg/dL. More than 50% of patients on higher doses achieved triglyceride levels of below 150 mg/dL (i.e., in the normal range) at 24 weeks.

    “Significant and durable dose-dependent reductions in ApoC3 and triglycerides persisted through week 48, or 36 weeks after patients received their second dose of plozasiran,” Gaudet said.

    Severe hypertriglyceridemia is a challenging condition for which few effective treatments are currently available, he said.

    “From the patients’ standpoint, the possibility that in the near future there could be an agent that safely and effectively lowers severely elevated triglyceride levels and reduces or eliminates the risk of developing pancreatitis is extraordinary,” he said.\

    Limitations of the study are its relatively small size and short duration and a lack of diversity among the enrolled patients, Gaudet said. The planned phase 3 study will be conducted in a patient population that will include more women and more patients from racial and ethnic minorities.

    “What we want to know is how sustained is the effect of plozasiran in a larger, more diverse cohort,” he said.

    The study was funded by Arrowhead Pharmaceuticals, the manufacturer of plozasiran.

    Gaudet will be available to the media in a press conference on Sunday, April 7, 2024, at 9:30 a.m. ET / 13:30 UTC in Room B203.

    Gaudet will present the study, “Plozasiran (ARO-APOC3), An Investigational RNAi Therapeutic, Demonstrates Profound And Durable Reductions In APOC-3 And Triglycerides (TG) In Patients With Severe Hypertriglyceridemia (SHTG), SHASTA-2 Final Results,” on Sunday, April 7, 2024, at 8:00 a.m. ET / 12:00 UTC in the Hall B-1 Main Tent.

    Source:

    American College of Cardiology

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  • Blood-based DNA test spares bladder cancer patients from unnecessary treatments

    Blood-based DNA test spares bladder cancer patients from unnecessary treatments

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    Testing for tumor DNA in the blood can successfully identify advanced bladder cancer patients who will not relapse following surgery, new research shows.

    This could allow doctors to target treatments more effectively to those who need it, and spare those patients for whom further treatment is unnecessary, researchers say.

    The findings from the screening phase of the IMvigor011 Phase III trial are presented today [Friday 5 April] at the European Association of Urology Congress in Paris.

    They show that just over 90% of muscle invasive bladder cancer (MIBC) patients with a negative circulating DNA (ctDNA) test following surgery, which remained negative on follow up, did not relapse. The findings mean that use of a ctDNA test could allow some patients to be spared further treatment with minimal risk.

    MIBC is an advanced form of bladder cancer, where the tumor has spread into the bladder wall. The disease is usually treated by surgery to remove the bladder. Around half of patients see cancer return, often in the lungs and usually within two-to-three years. All patients are currently offered follow-up treatment such as chemotherapy or immunotherapy to prevent recurrence, for which the side effects can be serious and lifechanging.

    Other Phase III trial results, also presented at the EAU Congress today, show that patients given immunotherapy, nivolumab, as a follow up to surgery have an average survival of nearly six years, compared to four for patients on placebo.

    The CheckMate 274 trial has already shown that nivolumab can reduce recurrence of disease, but these interim results are the first to show the potential benefit in overall survival for MIBC patients.

    Joost Boormans, Professor of Urology at Erasmus University Medical Centre in Rotterdam, and member of the EAU Scientific Congress Office, is chairing the session where both trials will present their findings. He said:

    “Although we already knew that nivolumab improved disease-free survival in MIUC patients who received radical surgery, overall survival is what really matters following local treatment, such as radical surgery. These interim findings, which show that overall survival also improves, are very encouraging, particularly as this hasn’t been the case in other recent immunotherapy trials.

    “The question for regulators and healthcare authorities is whether the improvement in overall survival is enough to justify licensing or prescribing the drug for all patients, in the knowledge that some of these patients would have been cured of their cancer by surgery alone. This is where the findings from the IMvigor011 trial could really make a difference, by allowing us to select patients at highest risk who will benefit the most from treatment while sparing others for whom it isn’t needed.

    “At a time when healthcare resources are under pressure, this kind of innovation is really needed.”

    IMvigor011

    IMvigor011 is a global, double-blind, randomized Phase III trial looking at the efficacy of the immunotherapy atezolizumab vs placebo in patients with high-risk MIBC.

    The trial is recruiting MIBC patients post-surgery and testing their blood for circulating tumour DNA. Those with a positive ctDNA result are randomized to receive either atezolizumab or placebo. Those with a negative result are given no further treatment, but were followed up with scans and further ctDNA tests for up to two years. For the analysis presented at the EAU Congress today, 171 patients with a negative ctDNA test were included, with follow up continuing on a further 115.

    Just 17 patients of the 171 patients (9.9%) saw their cancer return within two years. These outcomes were irrespective of the stage their tumor was at or whether it showed elevated levels of PD-L1, a protein biomarker that plays a role in cancer.

    Professor Thomas Powles of Barts Cancer Institute leads the IMvigor011 trial.

    These results are even better than we were hoping. The risk of relapse in this ctDNA group of patients is just 1 in 10. It appears this test can effectively filter patients into two groups: those who are likely to relapse and those at much lower risk. Focusing treatment on those at risk and sparing the very low risk group potentially life-altering treatment-related side effects is attractive. Hopefully these data will allow patients to remain treatment free with the reassurance they need, that they’re unlikely to see their cancer return.”


    Professor Thomas Powles of Barts Cancer Institute

    The study is sponsored by F. Hoffmann-La Roche Ltd.

    CheckMate 274

    CheckMate 274 is a global, Phase III, randomized, double-blind trial of nivolumab vs placebo in high-risk MIBC after surgery.

    The trial recruited just over 700 patients, with half given nivolumab and the other half given a placebo every two weeks for 12 months following an operation to remove the bladder. Patients were also tested to see if their cancer had elevated levels of the biomarker PD-L1, which nivolumab specifically targets.

    The trial has already reported positive results in preventing recurrence, particularly for PD-L1 patients. Across all patients, those on nivolumab had an average of 22 months before recurrence, compared to 10 months for those on placebo. However, of the PD-L1 group, those on nivolumab had an average of over four years without recurrence, compared to just over eight months for those on placebo.

    The latest results, although still early stage, show a similar benefit in overall survival. For all patients, those on nivolumab survive on average for nearly six years (69.5 months) compared to just over four years (50.1 months) for those on placebo. The researchers do not yet have enough follow-up data to separate out the PD-L1 patients, but the analysis so far shows that overall survival is likely to also be even better for this group when treated with nivolumab versus placebo.

    Professor Matthew Galsky from the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai in New York, leads the CheckMate 274 trial. He said: “We know that patients with high-risk urothelial cancer are at highest risk for recurrence within the first three years after surgery. We’ve now followed a substantial subset of patients for longer than that on this study without recurrence. It looks as if the improvement in disease free survival is ultimately going to translate into improvement in overall survival. And that’s for all patients, but particularly patients with the PD-L1 biomarker. Our hope is that this improvement will then translate into an increased likelihood of curing cancer in these patients.”

    The trial is funded by Bristol Myers Squibb and Ono Pharmaceutical. Dr. Matthew D. Galsky is a paid consultant to Bristol Myers Squibb.

    Source:

    European Association of Urology

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  • Statins linked to slight diabetes risk but benefits outweigh the concerns

    Statins linked to slight diabetes risk but benefits outweigh the concerns

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    In a recent study published in The Lancet Diabetes & Endocrinology, a large collaborative team of researchers investigated the factors associated with the increased risk of diabetes due to statin use, such as the types of individuals or populations that are at greater diabetes risk due to statin therapy, at what point after beginning statin therapy does the risk increase, and whether the use of statins has an impact on the glycemic control of known diabetes patients.

    Study: Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in large-scale randomised blinded statin trials: an individual participant data meta-analysis. Image Credit: Fahroni / ShutterstockStudy: Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in large-scale randomised blinded statin trials: an individual participant data meta-analysis. Image Credit: Fahroni / Shutterstock

    Background

    One of the leading causes of mortality across the world is cardiovascular disease, with low-density-lipoprotein (LDL) cholesterol being the major risk factor for atherosclerotic cardiovascular disease. The risk of atherosclerosis also increases significantly in diabetic patients. Treatment with statins such as 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor is believed to decrease the incidence of ischemic stroke and myocardial infarction by one-fourth for a reduction of 1 mmol/L LDL cholesterol reduction.

    However, findings from recent meta-analyses have indicated that standard regimens of statin therapy are linked to a 10% increase in new-onset diabetes risk, as compared to usual care for hypercholesteremia or placebo. The risk of new-onset diabetes was also found to be higher with more intense regimens of statin therapy. However, aspects of this association between statin use and diabetes risk, such as the populations at greater risk and the impact of statin use on individuals already diagnosed with diabetes, remain unclear.

    About the study

    In the present study, the researchers obtained information on adverse events related to diabetes, diabetes treatments, and records of glycemia measurements from participants registered in the Cholesterol Treatment Trialists’ Collaboration, which consisted of double-blinded, long-term, randomized controlled trials evaluating statin therapy.

    This study included statin therapy trials if they had a minimum of a thousand participants with a mean follow-up period of two years. Furthermore, the only differences mandated in the protocol of these trials had to be in the administration of statin therapy or placebo or the intensity of statin therapy. The individual participant data, which also included information on comorbidities, anthropometric measurements, and laboratory results for blood glucose tests, was used for a meta-analysis.

    The adverse events related to diabetes that were considered in the analysis included a diagnosis of diabetes, complications related to diabetes, such as glucose control and ketosis, or any other complications specific to diabetes. The medications for lowering glucose levels were identified from the prescription information using a standard drug dictionary, and fasting status was used to categorize the glucose concentrations.

    A history of diabetes, the occurrence of any diabetes-related adverse event, fasting blood glucose levels of 7 mmol/L or above, or the use of medications to lower blood glucose before the registration or assignment of the participant to the trial was used to define baseline diabetes. In those without baseline diabetes, the occurrence of any adverse event related to diabetes, a higher than the standard cut-off of blood glucose, or the use of any medication to lower blood glucose levels after the commencement of the trial were considered as new-onset diabetes diagnoses.

    Results

    The study found that statin use was indeed linked to an increase in new-onset diabetes, although the association was moderate and dose-dependent. Furthermore, while a slight increase in glycemia was observed after statin treatment, most of the diagnoses for new-onset diabetes were in individuals whose baseline glycemic markers were already quite close to the threshold for diagnosing diabetes.

    The potential increase in cardiovascular disease risk that could occur due to the marginal increase in glycemia was accounted for in the significant decrease in cardiovascular risk brought about by lowering LDL cholesterol due to statin therapy. Additionally, the impact of statin therapy on glycemic control in individuals with diabetes was not dissimilar from that observed in cases of new-onset diabetes.

    The results also suggested that the incidence rates of new-onset diabetes were significantly higher for the trials involving high-intensity statin regimens in both the intervention and placebo groups, as compared to trials evaluating moderate or low-intensity statin regimens. The researchers believe this significant difference in event rates could be because the trials evaluating the high-intensity regimens had a higher follow-up frequency, including more frequent blood glucose tests.

    Conclusions

    Overall, the findings suggested that while statin therapy was associated with an increase in the rate of new-onset diabetes diagnoses, the association was moderate and dose-dependent. Furthermore, the risk of new-onset diabetes was higher in individuals whose glycemic markers were already quite close to the threshold for diagnosing diabetes. Any potential increase in cardiovascular disease risk due to the hyperglycemic effect of statins was mitigated by the overall reduction in cardiovascular risk due to statin therapy.

    Journal reference:

    • Reith, C., Preiss, D., Blackwell, L., Emberson, J., Spata, E., Davies, K., … Marschner, I. (n.d.). Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in largescale randomised blinded statin trials: an individual participant data meta-analysis. The Lancet Diabetes & Endocrinology.  DOI: 10.1016/S22138587(24)000408, https://www.thelancet.com/journals/landia/article/PIIS2213-8587(24)00040-8/fulltext

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  • ADHD medication proves most effective in treating symptoms, new study finds

    ADHD medication proves most effective in treating symptoms, new study finds

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    In a recent review article published in Pediatrics, researchers provided a comprehensive overview of treatment options available for attention-deficit/hyperactivity disorder (ADHD) for children and adolescent individuals.

    Study: Treatments for ADHD in Children and Adolescents: A Systematic Review. Image Credit: ClareM/Shutterstock.comStudy: Treatments for ADHD in Children and Adolescents: A Systematic Review. Image Credit: ClareM/Shutterstock.com

    Background

    Using a systematic search across medical databases, they identified 312 intervention studies in 540 published articles that studied ADHD interventions lasting more than four weeks for individuals under the age of 18 who had been clinically diagnosed with ADHD.

    The outcomes included health and psychosocial indicators, and included studies compared the intervention group with active, passive, waitlist, placebo, or no treatment groups.

    They found promising evidence regarding the growing availability of several treatments that effectively treat symptoms of ADHD for school-aged and young populations and that while medication continues to be an important form of therapy, it is associated with numerous adverse effects.

    Medications to treat ADHD

    The review evaluated various medications for treating ADHD, including traditional stimulants like methylphenidate and amphetamines, as well as nonstimulants.

    Studies found that traditional stimulants significantly reduced ADHD symptom severity and broad measures but did not notably affect functional impairment.

    While methylphenidate formulations improved symptoms and appetite suppression, it was associated with more adverse events.

    Similarly, amphetamine formulations and norepinephrine reuptake inhibitors (NRIs)  also improved symptoms but suppressed appetite more and had more adverse events, while alpha-agonists were associated with fewer adverse effects.

    Nonstimulants significantly improved ADHD symptoms, broad measures, and disruptive behaviors but did not notably affect functional impairment.

    Direct comparisons between medications showed varied results, with some favoring stimulants over nonstimulants. However, combining nonstimulants with stimulants showed additional small improvements in symptoms.

    Overall, stimulants tended to be more effective in improving ADHD symptoms and broad measures compared to nonstimulants, with some variations in side effects and additional benefits when combined with nonstimulants.

    Integrative, alternative, or complementary therapies such as hippotherapy, homeopathy, and acupuncture were not associated with improvements in symptoms of ADHD or other outcome measures.

    Behavioral ADHD therapies

    Psychosocial interventions significantly improved ADHD symptoms across diverse approaches, including youth-directed interventions, parent support programs, and school-based interventions. However, these treatments did not notably affect disruptive behaviors or academic performance.

    Parent support programs also showed improved broadband scores and disruptive behaviors but not functional impairment.

    School interventions did not significantly affect ADHD symptoms but showed potential for enhancing academic performance.

    Cognitive training did not significantly improve ADHD symptoms but was effective in reducing disruptive behaviors and enhancing broadband measures.

    Neurofeedback, particularly targeting EEG markers, significantly improved ADHD symptoms with minimal heterogeneity, although its impact on disruptive behaviors and functional impairment was inconclusive.

    Overall, these findings suggest the efficacy of psychosocial interventions in alleviating ADHD symptoms in youth, with variations in effectiveness across different approaches and outcomes.

    Combining behavioral treatments and medication

    The reviewers found some studies that combined psychosocial treatments with medication (primarily atomoxetine or stimulants).

    Cognitive behavioral therapy, behavioral therapy, humanistic interventions, solution-focused therapy, and multimodal psychosocial treatments were included as behavioral treatments.

    These studies examined the effect of additional psychosocial treatment compared to medication alone and did not include placebo or no treatment arms.

    There was little evidence that combined therapy improved ADHD symptoms and other outcomes.

    Other key findings

    Nutrition interventions were generally placebo-controlled and included supplements and other dietary treatments, which were often administered in addition to stimulants.

    There were no supplements, including omega-3, which were associated with consistent improvements in outcomes. However, nutritional interventions were generally found to improve symptoms of ADHD and associated disruptive behaviors without increasing adverse effects.

    The study found limited evidence on whether different types of ADHD or coexisting psychiatric conditions influence treatment outcomes. Long-term follow-up data, especially beyond 12 months, were sparse across interventions.

    Studies, including those examining the effect of multimodal treatments, did not show sustained effects beyond 12 months across various interventions, except for some medication trials.

    Conclusions

    The review encompasses a comprehensive analysis of ADHD treatments, highlighting the effectiveness of diverse interventions across multiple domains.

    Medications, including stimulants and nonstimulants, show significant improvements in ADHD symptoms, with moderate to high strength of evidence. Psychosocial treatments, neurofeedback, and nutritional interventions demonstrate varied effectiveness, often with lower strength of evidence.

    Combining treatments was not found to consistently enhance outcomes. There is a dearth of studies on long-term effects and comparative effectiveness, emphasizing the need for more research to inform treatment decisions and improve patient care.

    The authors acknowledged that the scope of their review was limited by their eligibility criteria, excluding some earlier studies, psychosocial interventions, and studies with smaller sample sizes.

    Future research is required to analyze the comparative effectiveness of various treatments with network meta-analysis approaches.

    Journal reference:

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  • Pembrolizumab enhances breast cancer treatment regardless of age or menopausal status

    Pembrolizumab enhances breast cancer treatment regardless of age or menopausal status

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    New data from the KEYNOTE-756 phase 3 clinical trial show that adding the immunotherapy drug, pembrolizumab, to chemotherapy before and after surgery for breast cancer leads to better outcomes for patients regardless of their age or menopausal status.

    The findings, presented at the 14th European Breast Cancer Conference (EBCC 14) today (Wednesday), add to information available on the effect of pembrolizumab in patients with early-stage breast cancer that is at high risk of recurring or spreading further, and that is oestrogen receptor positive (ER positive) and HER2 negative.

    KEYNOTE-756 is an international trial, which has been running for eight years. It randomised 1278 patients to receive pembrolizumab or placebo in addition to neoadjuvant chemotherapy (given before surgery) followed by adjuvant (given after surgery) pembrolizumab or placebo in combination with an endocrine therapy. The patients had invasive ductal carcinoma (IDC), meaning the cancer had started to spread out of the milk ducts into the surrounding breast tissues.

    Professor Javier Cortés, Director of the International Breast Cancer Centre in Barcelona, Spain, said: “We have already reported that there was a statistically significant increase in the pathological complete response rate in patients receiving pembrolizumab compared to those receiving the placebo. The pathological complete response rate, meaning that no cancer cells remained in the breast or lymph nodes, was 24.3% in patients treated with pembrolizumab compared to 15.6% in patients treated with the placebo.

    “Now we can show that these pCR rates occurred regardless of the patients’ age or menopausal status. In patients younger than 50 years old, the pCR rate was 23.8% in those on pembrolizumab (76 out of 319 patients) compared to 16.9% (55 out of 326) for those receiving placebo, and was 24.7% (78 of 316 patients) versus 14.2% (45 of 317) respectively in those aged 50 or older. In pre-menopausal women, the pCR rate was 23.4% (83 out of 354 patients) versus 16.1% (57 out of 353) respectively, and in post-menopausal women, it was 24.8% (69 out of 278 patients) versus 14.6% (42 out of 287), respectively.

    “We also found that adding pembrolizumab to neoadjuvant chemotherapy did not delay the time to surgery. The average time to surgery in both groups of patients was about a month. The average time after surgery to the start of adjuvant treatment was 1.2 months in both groups.”

    The study found there were similar rates of breast-conserving surgery and mastectomy in both groups. Among the patients who had breast-conserving surgery, 41.3% (262 patients) received pembrolizumab and 43.7% (281 patients) received placebo. Among those who had a mastectomy, 55.3% (351 patients) were treated with pembrolizumab and 54.4% (350 patients) had the placebo.”

    Tissue collected at the time of surgery was analysed to see if any cancer cells remained after the neoadjuvant treatment, known as residual cancer burden (RCB). Neoadjuvant pembrolizumab resulted in a lower RCB for more patients, regardless of how well the immunotherapy had blocked a protein called PD-L1, which also drives some breast cancers.

    Pathology reports found that 35% of patients (222 patients) treated with pembrolizumab had no or very small amounts of cancer cells remaining (RCB 0-1) versus 23.6% of patients (152) receiving placebo. A moderate amount of RCB (RCB-2) was found in 40.8% of patients treated with pembrolizumab versus 45.3% (259 versus 291 patients), and extensive RCB (RCB-3) was found in 20.5% versus 28.9% of patients respectively (130 versus 186 patients).

    When the researchers looked at the effect of pembrolizumab according to whether patients had cancer that was ER positive in less than 10% of cells or in 10% or more, they found that 64.7% of patients (22 out of 34) with less than 10%, who were treated with pembrolizumab, had an RCB status of 0-1, compared to 37.2% of patients treated with placebo (16 out of 43). In patients with 10% or more ER positive cells, 33.3% compared to 22.7% had an RCB 0-1 status (200 out of 601 patients versus 136 out of 600 patients respectively).

    Dr Fatima Cardoso, Director of the Breast Unit of the Champalimaud Clinical Centre, Lisbon, Portugal, is the principal investigator for the trial. Speaking before EBCC 14, she said: “Keynote 756 trial showed that the addition of pembrolizumab to neoadjuvant chemotherapy significantly increased pathological response at the time of surgery, and this was true regardless of PD-L1 levels and estrogen receptor positivity. However, we saw a bigger benefit with higher PD-L1 levels and in ER-low tumors.

    “Keynote-756 is also the only trial that is powered to analyze the impact of immunotherapy in long-term outcomes for this subtype of breast cancer.”

    Adverse events from the treatments were unchanged from previous reports from the trial and were consistent with what is known already about each regimen.

    The trial continues to follow the patients, and information is being collected on survival rates and whether there are any recurrences of cancer or other related symptoms.

    Professor Michail Ignatiadis from the Institut Jules Bordet in Brussels, Belgium, is Chair of the 14th European Breast Cancer Conference and was not involved in the research.

    We have heard more data from the KEYNOTE-756 trial about which ER positive / HER2 negative patient subgroups benefit most from pembrolizumab in terms of pathological complete response. Longer follow-up is needed in order to see whether the improvement in pCR rates will result in more patients living for longer without their disease recurring, and we look forward to these data in due course.”


    Professor Michail Ignatiadis, Institut Jules Bordet in Brussels, Belgium

    Source:

    European Organisation for Research and Treatment of Cancer

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  • The impact on cognitive and physical performances

    The impact on cognitive and physical performances

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    In a recent study published in Nutrients, researchers examined the individual and combined effects of caffeine and creatine nitrate on cognitive and exercise performance by resistance-trained athletes.

    Study: The Effect of Creatine Nitrate and Caffeine Individually or Combined on Exercise Performance and Cognitive Function: A Randomized, Crossover, Double-Blind, Placebo-Controlled Trial. Image Credit: Ground Picture/Shutterstock.comStudy: The Effect of Creatine Nitrate and Caffeine Individually or Combined on Exercise Performance and Cognitive Function: A Randomized, Crossover, Double-Blind, Placebo-Controlled Trial. Image Credit: Ground Picture/Shutterstock.com

    Background

    Caffeine and creatine are dietary supplements that have demonstrated the ability to enhance training and exercise performance. Caffeine improves strength, muscular endurance, and anaerobic performance via binding to adenosine receptors, namely the A2A subtype.

    It also lowers pain and increases neuronal excitability. Creatine replaces adenosine triphosphate (ATP) during anaerobic exercise, thus increasing short-term power output and training volume. However, the interactions between caffeine and creatine are unclear.

    About the study

    In the present double-blinded, randomized, crossover, placebo-controlled trial, researchers at Jacksonville State University investigated the effects of seven-day high-dose caffeine, creatine nitrate, and their combination on severe intermittent exercise performance and mental attention in resistance-trained athletes.

    The team included 18–40-year-olds with ≥2.0 years of experience in multi-joint resistance exercise, no history of metabolic diseases (e.g., cardiovascular disease, diabetes, thyroid conditions, arrhythmia), and no prescription drug use.

    They excluded underweight or obese individuals (body mass index below 18.5 or above 24.9), smokers, those who consumed more than 12 alcoholic beverages per week, and those who were allergic to natural stimulants like caffeine.

    The researchers conducted the study in controlled settings, which included a 12-hour fast and a 48-hour break from exercise, caffeine, and certain drugs and supplements.

    They provided 12 resistance-trained male athletes with creatine nitrate [CN: (4 g creatine; 1 g nitrate), 5.0 g/d plus 0.7 g/d maltodextrin], caffeine (CAF: 400 mg/d + 5 g/d maltodextrin), or a mixture of the two.

    The subjects completed standardized resistance exercises (bench and leg press at 70% 1RM) and a Wingate anaerobic power test. The researchers assessed their cognitive performance and cardiovascular responses 45 minutes following the test.

    Following the cognitive function test, they measured participants’ performance preparedness using the Visual Analog Scale (VAS). The participants also completed detailed questionnaires to assess their sleep quality, coffee use, and any adverse effects they may have encountered.

    The athletes provided blood samples for safety examination, which included creatine kinase (CK), lactate dehydrogenase (LDH), alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT).

    The researchers performed a thorough lipid profile to assess total cholesterol (TC), high-density lipoproteins (HDL), low-density lipoproteins (LDL), very-low-density lipoproteins (VLDL), and triglycerides (TG).

    Participants completed four sets of three-day food diaries to evaluate their dietary consumption. The Stroop Word-Color Test was used to assess the effects of nutritional supplements on attention, processing speed, and cognitive flexibility.

    Results

    Creatine nitrate and caffeine combination treatment considerably improved cognitive function, notably in cognitive interference tests, while having little effect on short-term exercise performance.

    The Stroop Word-Color Interference test revealed a significant interaction effect between the two supplements, with the CO treatment producing a higher mean score than the CN treatment. The findings indicate that combination supplementation significantly affects cognitive processing.

    However, no supplement type showed unambiguous performance improvement across all or most outcomes, indicating a complicated interaction between caffeine and creatine.

    The observed gains from baseline in the Stroop Color and Word-Color interference tests following CO supplementation are consistent with previous research confirming creatine’s cognitive advantages.

    The improved cognitive performance in the CO group may indicate a synergistic impact of creatine when paired with CAF, perhaps increasing cognitive advantages through higher prefrontal cortex activation.

    The researchers also found that creatine supplementation had varying effects across different exercise modalities, particularly endurance sports, and in situations where extra body mass might impair performance.

    The Wingate test findings demonstrated consistent performance across markers such as peak power, mean power, minimum power, total work, and fatigue index, indicating that caffeine’s effects on anaerobic performance are less robust than previously assumed.

    The study supports a cautious approach to announcing the efficacy of CN and CAF as performance enhancers, bolstering the necessity for more research to untangle the numerous relationships impacting exercise results.

    The absence of significant changes in heart rate and blood pressure before and after exercise supports these supplements’ short-term cardiovascular safety.

    Conclusion

    The study found that consuming creatine nitrate and caffeine together enhances cognition in resistance-trained athletes for up to seven days without causing adverse effects. However, these supplements did not significantly improve exercise performance.

    The study validates the short-term safety of these supplements and recommends further investigation into their influences on cognitive and athletic performance over long periods and among varied demographics.

    Longitudinal research might provide insight into how these supplements affect muscle growth, intramuscular signaling networks, hormone responses, neuromuscular efficiency, and force generation. Future research should include female athletes to broaden the findings to gender-diverse groups.

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